Conference Day One
Wednesday, 26th June
8:00 am Check-In Opens & Light Breakfast
8:50 am Chair’s Opening Remarks
Unlocking the Importance for Adaptability on Release Assays & Explore the Complexities of Potency Assays to Aid Development of Effective Multi-Valent Vaccines
9:00 am Ensuring Adherence to Regulatory Guidelines for Release & Characterization Assays to Optimize Product Quality
- Kalavathi Dasuri CMC, Sanofi
- How can we differentiate the release and characterization assays for mRNA therapeutics?
- How can we integrate quality target product profiles (QTPP) into release and characterization assays?
- Emphasize the importance of adaptability to evolving regulatory standards for these assays
9:30 am Addressing the Need for Quantitative Potency Testing for mRNA Vaccines to Enhance Efficacy & Quality of Your mRNA Medicines
- Sarah Hymbaugh Senior Scientist, Seqirus Inc.
- What is the current state of potency testing and its impact on compliance and vaccine efficacy?
- What are the challenges of potency testing in mRNA vaccines and what is the need for quantitative assays?
- How can we find ways to achieve a more accurate correlation between RNA input and protein expression?
10:00 am Morning Break & Speed Networking
This session is the ideal opportunity to get face-to-face time with many of the brightest minds working in the mRNA Quality Control and Compliance field and establish meaningful business relationships to pursue for the rest of the conference
11:00 am Multi-Valent mRNA Vaccines: Strategies for Effective Design & Potency Assessment
- James Shuh Vice President Analytical Science, Abogen Biosciences
- Investigate the complexities of developing multi-valent mRNA vaccines to combat various infectious diseases
- What are quantitative potency assays for multi-valent vaccines and their challenges posed by variant-specific antibodies
- What are the potential engineering approaches to simplify potency assessments for multi-valent mRNA vaccines
11:30 am Roundtable Disussion: Innovations in Addressing Purification Challenges to Produce High Quality mRNA Therapeutics & Vaccines
- Craig Martin Professor, University of Massachusetts Amherst
- How can dsRNA effectively target specific mRNA sequences, resulting in increased specificity and accuracy in RNA analysis
- What are the possible strategies to improve its specificity and reduce the potential for off-target effects
- What are the regulatory hurdles in the use of dsRNA in mRNA development to ensure safety and efficacy of these technologies
- What are the current methods and techniques for ensuring a purified final product
12:30 pm Networking Lunch
Advancing Method Validation to Ensure Robustness & Navigate Strategies for Quality Control Testing & Documentation
1:30 pm Session Reserved for Boston Analytical
Session Details to be Announced
1:50 pm Diving into Method Validation Challenges & Ensuring Manufacturing Consistency in mRNA Production
- Yuqing Chang Associate Director, Beam Therapeutics
- What is the importance of consistent manufacturing and what are the potential variations that could impact product quality?
- What are the steps involved in validating manufacturing methods?
- How to ensure robustness in method validation
2:20 pm Exploring the Dynamic Nature of RNA Quality Control Considering Regulatory Strategies for Different Therapeutic Indications
- Monica Dommel Associate Director Regulatory Affairs CMC, CureVacSE
- Discuss the evolving landscape of RNA QC and compliance and highlight the importance of staying with the current regulatory changes
- Providing a step-by-step roadmap for regulatory compliance in mRNA quality control
- Discussing strategies for identifying, documenting, and addressing deviations
2:50 pm Afternoon Break & Poster Session
By joining our dedicated session, you will have the opportunity to engage in meaningful discussions with your peers about ongoing work in the field of mRNA therapeutics. As the discovery and development of these therapies continues to advance, it is essential to collaborate and share knowledge to streamline the approval process. Share your latest findings and gain insight into the cutting edge work of your peers. The goal of this session is to foster a sense of community and promote collaboration within the field.
Transforming the mRNA Quality Control Field via the Introduction to Platformization & Delving into High Quality Platform Analytics
4:00 pm Innovative mRNA Control Strategy – Rocking Out With AD/QC
- Abhita Malavia Director & Head Of Quality Control, Nutcracker Therapeutics
4:30 pm Phased Approaches for Elevated mRNA Quality Control in Platform Analytics
- Amanda Fisher Associate Director - Quality Control, Tessera Therapeutics
- What are the Standard Operating Procedures in ensuring consistency and repeatability in mRNA analysis
- How to complete high quality validated assays, reference materials, and data verification methods
- Highlight the iterative process of collecting data, analyzing trends, and refining protocols to enhance mRNA quality